NDC 0006-0221

JANUVIA

Sitagliptin

JANUVIA is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Sitagliptin Phosphate.

• Product ID: 0006-0221_18128ec1-8748-4f68-a7e8-f004ec697b29
• NDC: 0006-0221
• Product Type: Human Prescription Drug
• Proprietary Name: JANUVIA
• Generic Name: Sitagliptin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2006-10-16
• Marketing Category: NDA / NDA
• Application Number: NDA021995
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: SITAGLIPTIN PHOSPHATE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Dipeptidyl Peptidase 4 Inhibitor [EPC],Dipeptidyl Peptidase 4 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0006-0221-28

100 BLISTER PACK in 1 CARTON (0006-0221-28) > 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0221-01)

• Marketing Start Date: 2006-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-0221-54 [00006022154]

JANUVIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021995
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-16

NDC 0006-0221-01 [00006022101]

JANUVIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021995
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-16

NDC 0006-0221-28 [00006022128]

JANUVIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021995
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-16

NDC 0006-0221-31 [00006022131]

JANUVIA TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021995
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-10-16

Drug Details

Active Ingredients

Ingredient	Strength
SITAGLIPTIN PHOSPHATE	25 mg/1

OpenFDA Data

• SPL SET ID: f85a48d0-0407-4c50-b0fa-7673a160bf01
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • TS63EW8X6F
• RxNorm Concept Unique ID - RxCUI:
  • 665033
  • 665036
  • 665038
  • 665040
  • 665042
  • 665044
• UPC Code:
  • 0300060277313
  • 0300060112317
  • 0300060221316

Pharmacological Class

• Dipeptidyl Peptidase 4 Inhibitor [EPC]
• Dipeptidyl Peptidase 4 Inhibitors [MoA]

NDC Crossover Matching brand name "JANUVIA" or generic name "Sitagliptin"

NDC	Brand Name	Generic Name
0006-0112	JANUVIA	sitagliptin
0006-0221	JANUVIA	sitagliptin
0006-0277	JANUVIA	sitagliptin
50090-3472	JANUVIA	sitagliptin
50090-3527	JANUVIA	sitagliptin
50090-4084	JANUVIA	sitagliptin
50090-4086	JANUVIA	sitagliptin
50090-4087	JANUVIA	sitagliptin
50090-5517	JANUVIA	sitagliptin
50090-5547	JANUVIA	sitagliptin
50090-5585	JANUVIA	sitagliptin
55154-5040	JANUVIA	sitagliptin
55154-5042	JANUVIA	sitagliptin
55154-5044	JANUVIA	JANUVIA